This invention relates to the field of sampling air from the lungs and specifically to the field of obtaining a sample of a person's air, including alveolar air from the alveoli of the lungs of a person.
Air from the lungs of a person can be used for many different types of testing that would otherwise require the person to undergo an invasive procedure. For example, alveolar air can be analyzed for, but not limited to, the noninvasive diagnosis of a wide variety of conditions including the noninvasive diagnosis of stomach infections related to a high incidence of ulcers, enzymatic deficiencies, and metabolic conditions and/or abnormalities. Crucial to any such testing is the ability to get an accurate sample containing a sufficient volume of air representative of true alveolar air, necessary for specific testing.
Often times scientific testing apparatus' can be complicated, requiring a significant amount of user training and familiarity in order to master the operation of the apparatus and ensure consistent test results.
In the medical device industry, it is typically necessary to provide In-Service instruction for both operation and utilization of Medical Instrumentation. This requirement can be expensive and time-consuming for both manufacturer and users. Additionally, when personnel previously trained on the use of such instrumentation are transferred or otherwise leave the organization owning such devices, it is often common to have new users retrained by the manufacturer or the departing individual. This can prove problematic when the departing or departed individual is pressed into a hasty training session where time may not be sufficient for proper instruction. If a user requires re-training, or a new operator uses the machine, it is desirable to have a convenient training method to use.
Hydrogen and methane are produced in the digestive system primarily only by the bacterial fermentation of carbohydrates (sugars, starches or vegetable fibers), so if either of these gases appear in the expired air, it is usually a signal that carbohydrates or carbohydrate fragments have been exposed to bacteria, permitting such fermentation to take place. The generation of H2 and/or CH4 will result in the reabsorption of some of these gases into the blood stream from the site of their digestion, and they will appear in the expired air.
Bacteria are ordinarily not present in significant numbers in the small intestine, where digestion and absorption of sugars take place. Therefore, when a challenge dose (eg. lactose) is ingested, the level of hydrogen in alveolar air will rise significantly within one to two hours (depending on the intestinal transit time) only if the sugar is not digested and, therefore reaches the colon.
The breath-H2 test is a simple non-invasive procedure which is readily accepted by patients and staff, and which has greater reliability and acceptability than the blood test, according to many reports. The lower dose of lactose usually does not cause the discomfort and explosive diarrhea frequently seen by malabsorbers who are given the larger dose required for the blood test.
A study with over 300 patients showed that G-I symptoms after a lactose challenge are strongly associated with the amount of H2 excreted; the relationship between blood glucose change and symptom-severity was less evident.
False-positive breath-tests are rare, and when they occur they are usually caused by improperly doing the test—allowing the subject to smoke, sleep or eat shortly before or during the test. Bacterial overgrowth (from the colon retrograde into the small intestine) can also produce a false-positive breath-test, but it is usually preceded by an elevated fasting breath-H2 level and the response is seen soon after the sugar is ingested (within 20-30 minutes).
The incidence of false-negative results with the breath-test is well below that seen with the blood test. False-negative results are reported to be from 5-15% of all lactose malabsorbers, due to a variety of causes. Many of the false-negative reports can be avoided by measuring methane in addition to hydrogen because some methanogenic flora convert colonic H2 to CH4.